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Delirium Education, Prevention, and Management for ICU Delirium

N/A
Waitlist Available
Led By Kirsten Fiest, PhD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The ability to provide informed consent (both patient and family member; surrogate consent possible)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial will test whether educating families on delirium prevention, detection, and management will improve patient and family outcomes.

Who is the study for?
This trial is for adult ICU patients expected to stay in the ICU for at least another day and have a caregiver present. Participants must be alert enough (RASS ≥-3), able to give informed consent, and communicate effectively with research staff.Check my eligibility
What is being tested?
The study tests if educating family members on delirium can help prevent, detect, and manage it better than standard care alone. It aims to see if this reduces distress in families and improves outcomes like delirium prevalence, duration, severity, identification in medical records, and knowledge among caregivers.See study design
What are the potential side effects?
Since the intervention involves education rather than medication or invasive procedures, significant side effects are not anticipated. However, there may be emotional or psychological impacts on family members due to increased involvement in patient care.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You and your family understand and agree to participate in the study, or someone can give permission for you if needed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in proportion of generalized anxiety symptomatology in family members of critically ill patients measured by Generalized Anxiety Disorder-7 (GAD-7) compared between control and intervention.
Change in proportion of major depressive disorder symptomatology in family members of critically ill patients measured by Patient Health Questionnaire-9 (PHQ-9) compared between control and intervention.
Secondary outcome measures
Burden of delirium experienced by family members of critically ill patients measured by Caregiver Delirium Burden Instrument (DEL-B)
Identification of patient delirium in the medical charts
Psychological distress in family members of critically ill patients measured by Kessler Psychological Distress Scale (KPDS-10)
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intervention GroupExperimental Treatment2 Interventions
Patients and families will receive standard care, which is an informational pamphlet on ICU delirium upon admission. Additionally, they will receive delirium education on prevention and management of delirium.
Group II: Control GroupPlacebo Group1 Intervention
Patients and families will receive standard care, which is an informational pamphlet on ICU delirium upon admission. The intervention group will also receive the same pamphlet.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard Care
2018
Completed Phase 4
~3720

Find a Location

Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,333 Previous Clinical Trials
25,747,160 Total Patients Enrolled
University of CalgaryLead Sponsor
780 Previous Clinical Trials
841,536 Total Patients Enrolled
Kirsten Fiest, PhDPrincipal InvestigatorUniversity of Calgary
1 Previous Clinical Trials
70 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the ultimate aim of this clinical trial?

"This trial's principal aim is to assess the alteration in generalized anxiety symptomatology among family members of critically ill patients over a 3-month period post discharge, with Generalized Anxiety Disorder-7 (GAD-7) being used as an evaluative tool. Secondary outcomes include alterations in delirium severity levels as quantified by Intensive Care Delirium Screening Checklist scores pre and post intervention, retrospective review for patient delirium within medical charts, and changes in prevalence of said condition measured through ICDSC evaluations prior to treatment commencement."

Answered by AI

Are there openings available for participants in this experiment?

"Indeed, clinicaltrials.gov data confirms that this medical experiment is actively recruiting individuals. The trial was first published on January 13th 2020 and the most recent amendment was made October 7th 2021; 198 people need to be recruited from 4 different locations."

Answered by AI

How many participants are engaged in the experiment?

"Affirmative. Clinicaltrials.gov's information confirms that this clinical trial, which was initially published on January 13th of 2020, is still recruiting patients. A total of 198 participants must be enlisted from 4 distinct locations."

Answered by AI
~38 spots leftby Mar 2025